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A preliminary double-blind, placebo-controlled randomized study of baclofen effects in alcoholic smokers

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An Erratum to this article was published on 26 March 2015

Abstract

Rationale

There is presently no approved single treatment for dual alcohol and nicotine dependencies.

Objective

This pilot study investigated baclofen effects in alcoholic smokers.

Methods

This was a preliminary double-blind placebo-controlled randomized clinical study with 30 alcoholic smokers randomized to baclofen at 80 mg/day or placebo. A subgroup (n = 18) participated in an alcohol cue-reactivity experiment.

Results

Baclofen, compared with placebo, significantly decreased the percent days of abstinence from alcohol-tobacco co-use (p = 0.004). Alcohol dependence severity moderated baclofen effects, with the higher severity group having the greater baclofen response (p < 0.001). Although the percent days of alcohol-tobacco co-use declined in both groups, this decline was greater after placebo than baclofen (p < 0.001). Secondary analyses on alcohol or tobacco use alone suggested that the increase in percent days of co-abstinence was driven by the medication differences on heavy drinking days and on percent days smoking. In the cue-reactivity substudy, baclofen slightly decreased alcohol urge (p = 0.058) and significantly reduced salivation (p = 0.001), but these effects were not related to cue type.

Conclusions

This study provides preliminary evidence suggesting a possible role of baclofen in the treatment of alcoholic smokers. However, the mixed results and the small sample require larger confirmatory studies.

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Notes

  1. This substudy was funded when the main RCT was already ongoing, thus not all patients were able to participate in. Specifically, after it was funded, the cue-reactivity sub-study was offered to any ongoing participant at Week 6, and all individuals, among those who were invited, volunteered to take part in the sub-study. A separate consent form was obtained, which stated clearly that their decision to participate or not in the cue-reactivity substudy was completely independent and would not compromise their participation in the main treatment RCT

  2. Other parameters, including anxiety, saliva cotinine (nicotine metabolite) levels (Salimetrics, LLC, State College, PA), carbon monoxide (Smokerlyzer®; Bedfont Scientific Ltd.), and liver tests (GGT, AST, ALT) were not significantly different between the two groups either at baseline or during any other time point in the study (data not shown).

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Acknowledgments

The pilot treatment randomized clinical trial was supported by a grant from the ABMRF/The Foundation for Alcohol Research (PI: Leggio). The human laboratory cue-reactivity substudy was supported by an NIH grant jointly funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) and the National Institute on Drug Abuse (NIDA) (R03AA020169; PI: Leggio). Both grants were awarded to Dr. Leggio, while he was at Brown University. Dr. Leggio’s current work is supported by the NIAAA Division of Intramural Clinical and Biological Research and the NIDA Intramural Research Program.

Conflict of interest

Dr. Swift has received travel and honorarium from D&A Pharma, and consultant fees from CT Laboratories. Dr. Kenna has received consultant fees from CT Laboratories. The other authors report no biomedical financial interests or potential conflicts of interest.

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Authors and Affiliations

  1. Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, Laboratory of Clinical and Translational Studies, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, 10 Center Drive (10CRC/15330) MSC 1108; Room 1-5429, Bethesda, MD, 20892-1108, USA

    Lorenzo Leggio

  2. Intramural Research Program, National Institute on Drug Abuse, National Institutes of Health, Baltimore, MD, USA

    Lorenzo Leggio

  3. Department of Behavioral and Social Sciences, Center for Alcohol and Addiction Studies, Brown University, Providence, RI, USA

    Lorenzo Leggio

  4. Decision Sciences Institute, P.I.R.E, Pawtucket, RI, USA

    William H. Zywiak

  5. Butler Hospital, Providence, RI, USA

    William H. Zywiak

  6. Department of Psychiatry and Human Behavior, Center for Alcohol and Addiction Studies, Brown University, Providence, RI, USA

    William H. Zywiak, Jennifer W. Tidey, Robert M. Swift & George A. Kenna

  7. Department of Psychology, University of Nebraska-Lincoln, Lincoln, NE, USA

    Steven M. Edwards

  8. Veterans Affairs Medical Center, Providence, RI, USA

    Robert M. Swift

  9. Roger Williams Medical Center, Providence, RI, USA

    Robert M. Swift

Authors
  1. Lorenzo Leggio
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  2. William H. Zywiak
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  3. Steven M. Edwards
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  4. Jennifer W. Tidey
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  5. Robert M. Swift
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  6. George A. Kenna
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Corresponding author

Correspondence to Lorenzo Leggio.

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Supplemental Fig. 1S

Study flow chart (PPTX 81 kb)

Supplemental Fig. 2S

Effects of BACL vs. placebo in participants with high (>14.5) vs. low (<14.5) alcohol dependence scale (ADS) score on percent days abstinent from alcohol-tobacco co-use (PPTX 61 kb)

Supplemental Fig. 3S

Effects of BACL vs. placebo in participants with high (>7.5) vs. low (<7.5) nicotine dependence severity (Fagerström Test for Nicotine Dependence (FTND) score) on percent days abstinent from alcohol-tobacco co-use (PPTX 56 kb)

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Leggio, L., Zywiak, W.H., Edwards, S.M. et al. A preliminary double-blind, placebo-controlled randomized study of baclofen effects in alcoholic smokers. Psychopharmacology 232, 233–243 (2015). https://doi.org/10.1007/s00213-014-3652-9

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